About Biosimilars

The Opportunity to Improve Access to Therapies While Generating Significant Healthcare Savings

Biosimilars are new versions of existing biopharmaceuticals made in cellular biologic systems and are approved on the basis that they are highly similar to the reference product in terms of quality, safety, and efficacy. The term "biosimilars" is used to describe biologics developed to be highly similar to existing, branded biologics.1,2

Biosimilars are not called generics because biologic drugs cannot be exactly copied. Biologics are derived from living cells or organisms and consist of relatively large and often highly complex molecular entities that may be difficult to fully characterize.3

Rigorously Tested to Ensure Safety and Efficacy

Biosimilars follow an established development path to demonstrate and confirm that there are no clinically meaningful differences from their reference products:

Total global spending for cancer treatment was $100 billion in 2014, and healthcare providers and payers have concerns about the growing financial impact of these treatments for patients and providers.5

Biosimilars' Potential Impact on Reducing Healthcare Costs

Because biosimilars are designed to be similar to a biologic drug already on the market, they deliver comparable clinical, safety, and efficacy results as the reference biologics they are modeled after, but offer a cost savings to the healthcare system.1

US Department of Health and Human Services. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry. April 2015. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf.